CQA Vendor Oversight and Quality Assurance Lead (US)

Main Responsibilities and Accountabilities

• Vendor Lifecycle & Governance
• Define and execute risk-based vendor qualification and requalification strategies.
• In collaboration with R&D/Technical/Legal and QA Functional teams contribute to drafting, negotiating, and maintain Quality Agreements aligned to master service agreements.
• Establish and assure upkeep of vendor KPIs/SLAs, quality dashboards, and governance forums for performance, risk, and remediation tracking.
• Lead periodic vendor reviews (e.g., QBRs) as appropriate, ensuring KPIs achieve target level, actions, and corrective and preventive actions (CAPAs) are implemented/verified to assure the overall health of the relationship.
• Inspections
• Support planning of routine GxP audits of CROs, CMOs, labs, and system/service providers; ensuring findings are classified, graded, and reported internally and externally.
• Liaise with Vendors/Suppliers to assure corrective and preventative CAPA’s are defined and fit-for-purpose. Perform follow up effectiveness checks.
• Career Development
• Coordinate inspection readiness and provide front/backroom support when third party services are in scope, support development of storyboards.
• Maintain auditee scheduling, auditor qualification, and audit program metrics.
• Quality Systems & Compliance
• Ensure vendor practices meet GLP/GCP/GMP/GVP, ICH, OECD, ISO, and data integrity principles (ALCOA+).
• Provide input to deviation, complaint, change control, and CAPA processes involving third parties; participate in root cause analysis where appropriate.
• Contribute to the Quality Management System (QMS)—procedures, templates, and training—for third party oversight.
• Risk Management & Continuous Improvement
• Lead risk assessments (e.g., risk registers, FMEA) to prioritize controls and monitoring frequency for specific vendors/suppliers.
• Drive quality improvements with vendors (process robustness, right first time (cycle time reduction, etc.)).
• Analyze trends (audit findings, deviations, complaints) and present management reviews with actionable insights.
• Cross Functional Partnership
• Collaborate with Clinical Operations, Nonclinical, CMC, Safety, Supply Chain, Procurement, Legal, and IT to embed quality requirements in scopes of work and contracts.
• Provide guidance during technology transfers, method validations, sample handling, and data flows between sponsor and vendors.
• Act as CSL Person-in-Plant as appropriate to provide contemporaneous quality support to CSL specific vendor operations.
• Train internal stakeholders on third party quality expectations and best practices.
• Maintain and share knowledge of Regulations and Requirements
• Stay current and up to date with GxP regulations and requirements related to audit management as well as industry/regulatory trends in this area.
• Identify and/or create new requirements to ensure a high level of quality and communicate internally.